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NDC 68196-0370-16 Hand Sanitizer 700 mg/mL Details

Hand Sanitizer 700 mg/mL

Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Sam's West Inc.. The primary component is ALCOHOL.

Product Information

NDC	68196-0370
Product ID	68196-370_cb5c39c6-6207-4013-ba61-cfe83a804034
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	700
Active Ingredient Units	mg/mL
Substance Name	ALCOHOL
Labeler Name	Sam's West Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68196-0370-16 (68196037016)

Pricing Information	N/A
NDC Package Code	68196-370-16
Billing NDC	68196037016
Package	59 mL in 1 BOTTLE, PLASTIC (68196-370-16)
Marketing Start Date	2017-08-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d1c49c3c-53ee-4914-aa02-cd84057254a2 Details

Active ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

to decrease bacteria on the skin that could cause disease
recommended for repeated use

Warnings

For external use only

Flammable, keep away from heat or flame.

When using this product

keep out of eyes. In case of contact with eyes, flush thoroughly with water.
avoid contact with broken skin
do not inhale or ingest

Stop use and ask a doctor

irritation and redness develop
condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hands thoroughly with product and allow to dry without wiping
for children under 6, use only under adult supervision
not recommended for infants

Other information

do not store above 105⁰ F
may discolor some fabrics
harmful to wood finishes and plastics

Inactive ingredients

water, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4

SPL UNCLASSIFIED SECTION

*Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds.

**Meets the FDQA healthcare personnel hand wash criteria.

Distributed by Sam's West, Inc., Bentonville, AR 72716

We would love to hear from you! Call us at: 1-888-301-0332 8am-5pm Monday-Friday

Pat. 9161,982

DSP-MO-28 DSP-MO-34

370.000/370AB

principal display panel

Member's Mark

hand sanitizer

Vitamin E

Moisturizers

Kills more than 99.99% of germs in 15 seconds*

Formulated for healthcare** gentle enough for everyday use

67.6 FL OZ (2 L)

INGREDIENTS AND APPEARANCE

HAND SANITIZER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68196-370
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	700 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SULISOBENZONE (UNII: 1W6L629B4K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68196-370-16	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/17/2017
2	NDC:68196-370-88	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/17/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/17/2017

Labeler - Sam's West Inc. (051957769)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(68196-370)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(68196-370)

Revised: 9/2022

Document Id: cb5c39c6-6207-4013-ba61-cfe83a804034

Set id: d1c49c3c-53ee-4914-aa02-cd84057254a2

Version: 10

Effective Time: 20220906